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This study came out in my company today (Novartis) We all know femara is better than nolvadex, regardless, this study may be interesting to some.
San Antonio, TX, December 10, 2001 – New data suggest Femara may be more effective than tamoxifen in treating postmenopausal women with ER and HER-2 positive breast cancer, according to findings presented today at the 24th Annual San Antonio Breast Cancer Symposium. The results are based on an analysis of breast tumor samples obtained from a subset of patients in a prospective randomized study comparing the neo-adjuvant (pre-operative) use of Femara versus tamoxifen in postmenopausal women. Based on tissue samples taken from a subset of the 337 patients in the clinical study who had confirmed ER+ and ErbB1+ (EGF receptor) and/or ErbB2+ (HER-2/neu receptor) tumors (n=36), had a significantly greater response rate with Femara than with tamoxifen (Femara 88% vs. tamoxifen 21%, p= 0.0004).
"Our clinical data already demonstrate that Femara is more effective than tamoxifen in treating postmenopausal women with hormone sensitive advanced breast cancer," said Matthew Ellis, MD, Ph.D., FRCP, Clinical Director, Duke Breast Cancer Program, Duke University Medical Center and lead investigator in the study. "These new results suggest Femara may be effective in treating postmenopausal women with very difficult to treat disease -- HER-2 positive breast cancers."
Study Background
In this study, immunohistochemistry of molecular biomarkers was used to investigate the biological basis for activity of an aromatase inhibitor (Femara) and an antiestrogen (tamoxifen), and to further evaluate mechanisms of action that could potentially explain any treatment effect differences. The molecular markers that were assessed included Ki67 (a marker of cellular proliferation) and ErbB1 (EGF) and ErbB2 (HER-2/neu) receptors on tumor cells.
These data further support results of a Phase III study presented at San Antonio that demonstrates Femara offers superior time to progression (TTP) and overall response rate, and a survival advantage compared to tamoxifen in the first-line hormonal treatment of postmenopausal women with advanced breast cancer.
Novartis is further evaluating Femara compared to tamoxifen in the adjuvant setting. One study is a multinational adjuvant (post-operative) clinical trial evaluating disease-free and overall survival in women with breast cancer who take Femara after having remained disease-free with five years of tamoxifen therapy. A second trial compares five years of Femara to five years of tamoxifen, and to the sequence of two years of Femara and three years of tamoxifen or the reverse – two years of tamoxifen and three years of Femara. These large studies expect to complete enrollment in mid-2002.
About Femara
Femara, an aromatase inhibitor, is an oral once-a-day first-line treatment for postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer. The U.S. Food and Drug Administration (FDA) approved Femara for this indication in January 2001, and it is currently available in more than 75 countries worldwide with first-line approval already gained in more than 50 countries.
Femara is contraindicated for patients with known hypersensitivity to letrozole or any Femara excipients. Femara is generally well tolerated and adverse reaction rates in the first-line study in which Femara was compared to tamoxifen were similar with those seen in second-line studies. The most commonly reported adverse events for Femara vs. tamoxifen were bone pain (22% vs. 21%), hot flushes (19% vs. 16%), back pain (18% vs. 19%), nausea (17% vs. 17 %), dyspnea or labored breathing (18% vs. 17%), arthralgia (16% vs. 15%), fatigue (13% vs. 13%), coughing (13% vs. 13%) and constipation (10% vs. 11%). Femara may cause fetal harm when administered to pregnant women. The incidence of peripheral thromoembolic events, cardiovascular events and cerebrovascular events was ≤ 2%. There is no clinical experience to date on the use of Femara in combination with other anticancer agents.
The foregoing release contains forward-looking statements that can be identified by terminology such as "significantly greater," "demonstrate," "more effective," "further support," "survival advantage," or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Femara to be materially different from any future results, performance or achievements expressed or implied by such statements. In particular, management's expectations regarding further commercialisation of Femara could be affected by, among other things, additional analysis of data; new data; unexpected clinical trial results; clinical trial results for competitor’s products; unexpected regulatory actions or delays or government regulation generally; the company’s ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; and other risks and factors referred to in the Company’s current Form 20-F on file with the Securities and Exchange Commission of the United States. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected.
About Novartis
Novartis Oncology is a business unit within Novartis AG (NYSE: NVS), a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 2000, the Novartis Group's ongoing businesses achieved collective sales of CHF 29.1 billion (USD 17.2 billion) and a net income of CHF 6.5 billion (USD 3.9 billion). The Group invested approximately CHF 4.0 billion (USD 2.4 billion) in R&D. Novartis AG is headquartered in Basel, Switzerland. Novartis Group companies employ about 70,000 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
San Antonio, TX, December 10, 2001 – New data suggest Femara may be more effective than tamoxifen in treating postmenopausal women with ER and HER-2 positive breast cancer, according to findings presented today at the 24th Annual San Antonio Breast Cancer Symposium. The results are based on an analysis of breast tumor samples obtained from a subset of patients in a prospective randomized study comparing the neo-adjuvant (pre-operative) use of Femara versus tamoxifen in postmenopausal women. Based on tissue samples taken from a subset of the 337 patients in the clinical study who had confirmed ER+ and ErbB1+ (EGF receptor) and/or ErbB2+ (HER-2/neu receptor) tumors (n=36), had a significantly greater response rate with Femara than with tamoxifen (Femara 88% vs. tamoxifen 21%, p= 0.0004).
"Our clinical data already demonstrate that Femara is more effective than tamoxifen in treating postmenopausal women with hormone sensitive advanced breast cancer," said Matthew Ellis, MD, Ph.D., FRCP, Clinical Director, Duke Breast Cancer Program, Duke University Medical Center and lead investigator in the study. "These new results suggest Femara may be effective in treating postmenopausal women with very difficult to treat disease -- HER-2 positive breast cancers."
Study Background
In this study, immunohistochemistry of molecular biomarkers was used to investigate the biological basis for activity of an aromatase inhibitor (Femara) and an antiestrogen (tamoxifen), and to further evaluate mechanisms of action that could potentially explain any treatment effect differences. The molecular markers that were assessed included Ki67 (a marker of cellular proliferation) and ErbB1 (EGF) and ErbB2 (HER-2/neu) receptors on tumor cells.
These data further support results of a Phase III study presented at San Antonio that demonstrates Femara offers superior time to progression (TTP) and overall response rate, and a survival advantage compared to tamoxifen in the first-line hormonal treatment of postmenopausal women with advanced breast cancer.
Novartis is further evaluating Femara compared to tamoxifen in the adjuvant setting. One study is a multinational adjuvant (post-operative) clinical trial evaluating disease-free and overall survival in women with breast cancer who take Femara after having remained disease-free with five years of tamoxifen therapy. A second trial compares five years of Femara to five years of tamoxifen, and to the sequence of two years of Femara and three years of tamoxifen or the reverse – two years of tamoxifen and three years of Femara. These large studies expect to complete enrollment in mid-2002.
About Femara
Femara, an aromatase inhibitor, is an oral once-a-day first-line treatment for postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer. The U.S. Food and Drug Administration (FDA) approved Femara for this indication in January 2001, and it is currently available in more than 75 countries worldwide with first-line approval already gained in more than 50 countries.
Femara is contraindicated for patients with known hypersensitivity to letrozole or any Femara excipients. Femara is generally well tolerated and adverse reaction rates in the first-line study in which Femara was compared to tamoxifen were similar with those seen in second-line studies. The most commonly reported adverse events for Femara vs. tamoxifen were bone pain (22% vs. 21%), hot flushes (19% vs. 16%), back pain (18% vs. 19%), nausea (17% vs. 17 %), dyspnea or labored breathing (18% vs. 17%), arthralgia (16% vs. 15%), fatigue (13% vs. 13%), coughing (13% vs. 13%) and constipation (10% vs. 11%). Femara may cause fetal harm when administered to pregnant women. The incidence of peripheral thromoembolic events, cardiovascular events and cerebrovascular events was ≤ 2%. There is no clinical experience to date on the use of Femara in combination with other anticancer agents.
The foregoing release contains forward-looking statements that can be identified by terminology such as "significantly greater," "demonstrate," "more effective," "further support," "survival advantage," or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Femara to be materially different from any future results, performance or achievements expressed or implied by such statements. In particular, management's expectations regarding further commercialisation of Femara could be affected by, among other things, additional analysis of data; new data; unexpected clinical trial results; clinical trial results for competitor’s products; unexpected regulatory actions or delays or government regulation generally; the company’s ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; and other risks and factors referred to in the Company’s current Form 20-F on file with the Securities and Exchange Commission of the United States. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected.
About Novartis
Novartis Oncology is a business unit within Novartis AG (NYSE: NVS), a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 2000, the Novartis Group's ongoing businesses achieved collective sales of CHF 29.1 billion (USD 17.2 billion) and a net income of CHF 6.5 billion (USD 3.9 billion). The Group invested approximately CHF 4.0 billion (USD 2.4 billion) in R&D. Novartis AG is headquartered in Basel, Switzerland. Novartis Group companies employ about 70,000 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
